Non-luer connectors

ABSTRACT

Drug delivery devices having integrated non-luer connectors are described. An exemplary drug delivery device includes a container with a non-luer connector that prevents connection of a standard female luer connector to the container. One or more embodiments pertain to a container with a non-luer connector that prevents the formation of a fluid-tight seal between a standard female luer connector and the container. A non-luer connector for attachment to a container having a non-luer element is also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/210,966, filed Aug. 16, 2011, now U.S. Pat. No. 9,814,870 issued onNov. 14, 2017, which claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Application No. 61/374,325, filed Aug. 17, 2010, thedisclosures of which are incorporated herein by reference in theirentirety.

TECHNICAL FIELD

Aspects of the present invention relate to non-luer connectors for usewith drug delivery systems that prevent misconnection with standard maleand female luer connectors.

BACKGROUND

Connectors used with drug delivery devices typically share a common ISOstandard luer connection. A standard luer tip or standard male connectorhas specifications as provided by the International Organization forStandardization (ISO) in ISO 594-1:1986 and 594-2:1998, including a 6%taper that increases from the open distal end to the proximal end and anouter cross-sectional diameter at the distal end of the tip measuringbetween about 0.1545 inches (3.925 mm) and about 0.1570 inches (3.990mm) for rigid material and between about 0.1545 inches (3.925 mm) andabout 0.1585 inches (4.027 mm) for semi-rigid material. A standard luerhub or standard female luer connector may have a 6% taper that decreasesfrom the open proximal end to the distal end and an innercross-sectional dimension at the open proximal end measuring betweenabout 0.168 inches (4.270 mm) to about 0.170 inches (4.315 mm). Inembodiments of standard female luer connectors that incorporate tabs orlugs for connection to a corresponding male luer lock connector, theouter cross-sectional dimension of the standard female luer connector,including the lugs, is in the range from about 0.307 inches (7.80 mm) toabout 0.308 inches (7.83 mm). In embodiments of standard female luerconnectors that do not incorporate tabs or lugs for connection to acorresponding male luer lock connector, the outer cross-sectionaldimension may be about 0.224 inches (5.700 mm) for rigid connectors andabout 0.265 inches (6.730 mm) for semi-rigid connectors, based on themaximum outside diameter of the standard female luer connector at thebase of the lugs of ISO 594-2. The minimum length of the standard luertip and/or the standard luer hub is 0.295 inches (7.500 mm), accordingto ISO 594-1. As used herein, the phrases “standard male luer connector”and “standard female luer connector” shall refer to connectors havingthe above dimensions.

Standard luer male connectors and standard female connectors,collectively referred to herein as standard luer connectors, may be usedin intravascular, anesthesia and enteral delivery systems and mayinclude structure that allows a drug delivery device for one system tobe to be compatible with other systems. For example, some neuraxial drugdelivery systems may use the same type of standard luer connector as theconnectors used with other delivery applications, for example, centralintravenous catheters, central venous pressure parts, infusion ports,balloon ports, introducer ports, IV luer connectors, peritoneal dialysiscatheters, distal port for a pulmonary artery catheter, and many otherconnectors. An unintended consequence of connecting a drug deliverysystem for one type of delivery system to connectors for use with othertypes of delivery systems is that such connection would provide a linkbetween two unrelated systems, i.e., neuraxial to intravenous (IV). Eachdelivery system is intended to provide unique methods of delivery, withdistinctly different purposes and different medications, which theinterchangeability of known drug delivery systems can circumvent. Suchcircumvention can lead to harm and/or serious injury to the patient.

Limiting the use of standard luer connectors for vascular access orsystems is one consensus accepted by device manufacturers and regulatorybodies. Accordingly, there has been a need to modify all other devicesso they have a different type of connector that cannot physicallyconnect with a standard luer connector or incompatible devices. Newproposed standards for small bore connectors, for example ISO 80369-6for neuraxial applications, have also propelled the need for suitablenon-luer connectors. These new proposed standards include connectorswith a 5% taper, instead of a 6% taper that is currently used withstandard luer connectors. In addition, the new standards proposeconnectors with smaller inner and outer cross-sectional dimensions andlonger lengths than standard luer connectors.

Attempts to prevent or minimize misconnections between drug deliverysystems include educating practitioners about misconnections, labelingand color-coding. However, these attempts offer only temporarysolutions. The use of adapters which provide a removable non-lueradapter also does not provide a permanent solution that is free of orreduces human error. Other solutions require the use of adapters toenable users to fill the medication to be administered into the drugdelivery system because the drug delivery system is not compatible withstandard ampoules, vials or other containers.

There is a need for non-luer connectors for use with drug deliverysystems that prevent misconnection with standard luer connectors andother unintended drug delivery systems.

SUMMARY

In this disclosure, a convention is followed wherein the distal end ofthe device is the end closest to a patient and the proximal end of thedevice is the end away from the patient and closest to a practitioner.

As used herein, the term “dimension” shall include the length, diameteror width of a geometric shape or the geometrically shaped componentsdescribed herein. The term “cross-sectional dimension” shall include themeasurement of the longest distance or greatest distance between twopoints on an edge of a cross-section of an object or component with acircular or non-circular cross-section. The two points may be located onthe inside surface or outside surface of the edge of the cross-sectionof the object. The cross-sectional dimension of two points located onthe inside surface of the edge of the cross-section of the object shallbe referred to as the “inside cross-sectional dimension” and thecross-sectional dimension of two points located on the outside surfaceof the edge of the cross-section of an object shall be referred to asthe “outside cross-sectional dimension.” It should be recognized that“cross-sectional dimension” of objects having a circular cross-sectionmay be referred to as the “diameter” of the object. The terms“cross-sectional dimension” and “diameter” may be used interchangeablyfor objects having a circular cross-section.

The drug delivery systems of one or more embodiments described hereinmay be used for neuraxial, anesthesia, intravascular or other drugdelivery applications.

A first aspect of the present invention pertains to a non-luer connectorfor connection to a second non-luer connector. In one or moreembodiments, the non-luer connector includes a container including anopen distal end including a distal wall and a sidewall extending in aproximal direction from the distal wall. The sidewall includes an insidesurface defining a fluid chamber for retaining fluids. The containeralso includes an elongate tip extending in a distal direction from thedistal wall. The elongate tip includes an opening providing access tothe chamber, an outside surface and a distal end.

In one or more embodiments, the outside surface of the elongate tipincludes an outer cross-sectional dimension measured at the distal endof the tip of 0.1545 inches or less. In one or more specificembodiments, the outer cross-sectional dimension of the elongate tipmeasured at the distal end of the tip is in the range from about 0.100inches to about 0.145 inches. In an even more specific embodiment, theouter cross-sectional dimension of the elongate tip measured at thedistal end of the elongate tip is in the range from about 0.1306 inchesto about 0.1326 inches.

The elongate tip of one or more embodiments may have a length, measuredfrom the distal wall of the container to the distal end of the elongatetip in the range from about 0.200 inches to about 0.500 inches.

The outside surface of the elongate tip may have a taper of less than 6%that decreases in a proximal to distal direction. In one or morespecific embodiments, the taper of the outside surface may be in therange from about 3% to about 5.9%.

In one or more embodiments, the outside surface of the elongate tip mayhave a taper of more than 6% that decreases in a proximal to distaldirection.

The non-luer connector of one or more embodiments may further include afemale non-luer connector that is removably attached to the elongate tipof the container. In one or more embodiments, the female non-luerconnector includes a hub body with an open proximal end and an interiorsurface defining a cavity. The hub body may optionally include a needlecannula attached thereto. The needle cannula may include an openproximal end in fluid communication with the opening of the container.

In one or more embodiments, the cavity of the hub body may have an innercross-sectional dimension measured at the open proximal end of less than0.168 inches, measured at the open proximal end. In one or more specificembodiments, the cavity of the hub body may have an innercross-sectional dimension at a proximal end in the range from about0.110 inches to about 0.150 inches. In an even more specific embodiment,the cavity of the hub body has an inner cross-sectional dimensionmeasured at the open proximal end in the range from about 0.1417 inchesto about 0.1437 inches.

The cavity of one or more embodiments of the female non-luer connectormay have a length in the range from about 0.250 inches to about 0.500inches.

In one or more embodiments, the interior surface of the cavity has taperof less than 6% decreasing in a proximal to distal direction. In one ormore specific embodiments, the interior surface of the cavity has ataper decreasing in a proximal to distal direction in the range fromabout 3% to about 5.9%, or alternatively, in the range from about 0.5%to about 2.9%.

In one or more embodiments, the interior surface of the cavity has taperof more than 6% decreasing in a proximal to distal direction.

In one or more embodiments, the elongate tip of the container mayinclude a square cross-sectional shape. In one or more specificembodiments, the outside surface of the elongate tip may include asquare cross-sectional shape. The cavity of the female non-luerconnector of one or more embodiments may have an interior surface havinga square cross-sectional shape. The female non-luer connector may alsohave an inner cross-sectional dimension selected to form a fluid-tightseal with the elongate tip, or more specifically, the outside surface ofthe elongate tip. In one or more alternative embodiments, the elongatetip may have a circular cross-sectional shape. The cavity of the femalenon-luer connector may have an inner cross-sectional dimension selectedto form a fluid-tight seal with the elongate tip. Specifically, theshape and/or size of the inner cross-sectional dimension of the cavitymay be selected to form a fluid-tight seal with the outside surface ofthe elongate tip.

A second aspect of the present invention pertains to a non-luerconnector for connection to a female non-luer connector that includes anon-luer element. In one or more embodiments, the non-luer connectorincludes a container having an open distal end including a distal walland a sidewall that extends in a proximal direction from the distalwall. The sidewall may include an inside surface that defines a fluidchamber for retaining fluids. The container may also include an elongatetip that extends in a distal direction from the distal wall. Theelongate tip includes an opening for providing access to the chamber. Inone or more embodiments, a non-luer element is disposed at the opendistal end of the container for preventing fluid-tight connection of astandard luer connector to the container.

In one or more embodiments, the elongate tip includes an outside surfaceon which the non-luer element may be disposed. The non-luer element ofone or more variants may include an exterior surface with an outercross-sectional dimension that is greater than the outer cross-sectionaldimension of the elongate tip. The outer cross-sectional dimension ofthe non-luer element may also be greater than an inner cross-sectionaldimension of a standard female luer connector. The outer cross-sectionaldimension of the non-luer element may prevent connection of a standardfemale luer connector to the elongate tip. In one or more alternativeembodiments, the exterior surface of the non-luer element has one of acircular cross-sectional shape, a square cross-sectional shape and atriangular cross-sectional shape.

Embodiments of the non-luer connector according to the second aspect mayinclude a female non-luer connector being removably attached to theelongate tip of the container, as otherwise described herein. In one ormore embodiments, the female non-luer connector may have a cavity withcross-sectional dimension selected to form a fluid-tight seal with theelongate tip or, more specifically, with the outside surface of the tip.

In one or more embodiments, the non-luer element extends in a distaldirection from the distal wall of the container. The non-luer elementmay be disposed coaxially around the elongate tip and form a channelbetween the elongate tip and the non-luer element for receiving aportion of a female non-luer connector. In one or more variants, theinner cross-sectional dimension of the non-luer element may be greaterthan an inner cross-sectional dimension of a standard female luerconnector and less than an outer cross-sectional dimension of thestandard female luer connector. In one or more alternative embodiments,the non-luer element has one of a circular cross-section, a squarecross-section and a triangular cross-section. The non-luer element ofone or more embodiments may include at least one aperture that providesaccess to the channel. In one variant, the non-luer element includes atleast two apertures and includes a curved cross-sectional shape betweenthe two apertures. In another variant, the non-luer element includes adistal end and a proximal end and the at least one or two aperturesextends from the distal end to the proximal end of the non-luer element.In yet another variant, the at least one or two apertures extends fromthe distal end to a distance partially between the distal end and theproximal end of the non-luer element. The aperture or apertures providedin one or more embodiments may provide visual indication of whether thenon-luer connector comprises a luer slip fitting or a luer lock fitting.The non-luer connector of one or more embodiments may incorporate an atleast one aperture that has a dimension selected to prevent formation ofa fluid-tight seal between the non-luer element and a standard femaleluer connector. In one variant, the distal end of the non-luer elementextends distally past the elongate tip. In another variant, the elongatetip includes a distal end that extends distally past the distal end ofthe non-luer connector.

In one or more embodiments in which the non-luer element is disposedcoaxially around the elongate tip, the non-luer connector may include afemale non-luer connector removably attached to the elongate tip of thecontainer, as described herein. In one or more embodiments, the femalenon-luer connector may include a hub body and a cavity dimensioned forfluid-tight connection of the female non-luer connector to the elongatetip. In one or more embodiments, the cavity of the female non-luerconnector may have a cross-sectional dimension selected to form afluid-tight seal with the elongate tip.

In one or more embodiments, the non-luer element may be provided on thenon-luer connector at a distal end of the elongate tip. The non-luerelement may be disposed at the distal end of the elongate tip forpreventing the formation of a fluid tight seal between the elongate tipand a standard female luer connector. In one or more embodiments, theelongate tip may include a body wall with an outside surface extendingfrom the distal end to the distal wall of the container and the non-luerelement includes a notch in fluid communication with the opening of theelongate tip for extending the opening across the distal end of theelongate tip to the outside surface of the body wall of the elongatetip. In one or more specific embodiments, the non-luer element includesa plurality of notches disposed on the distal end of the elongate tip.The plurality of notches may be disposed adjacent to one another alongthe circumference of the distal end of the tip and may surround theopening of the tip. In one or more variants, the plurality of notcheshaving a wedge shape that extends into the distal end of the elongatetip. The length of the elongate tip may vary along the plurality ofnotches. Specifically, the elongate tip may have a length that increasesalong the distal end from the opening of the tip to the outside surfaceof the tip. In one or more embodiments, the outside surface of theelongate tip has a taper of 5% decreasing in a proximal to distaldirection. The tip may also have an outer cross-sectional dimensionsized to prevent connection of a standard female luer connector to thecontainer.

Embodiments of the non-luer connector that includes a notch, notches ora plurality of notches may include a female non-luer connector beingremovably attached to the elongate tip, as otherwise described above.The female non-luer connector may include an interior surface defining acavity dimensioned for fluid-tight connection of the female non-luerconnector to the elongate tip. In one or more embodiments, uponattachment of the female non-luer connector to the container, the notchmay be in contact with the interior surface of the hub body and afluid-tight seal is formed between the distal end of the elongate tipand the female non-luer connector. In one or more alternativeembodiments, upon attachment of a standard female luer connector to thecontainer, the notch is disposed at a distance from an inside surface ofthe standard female luer connector, preventing formation of afluid-tight seal between the distal end of the elongate tip and thestandard female luer connector. The interior surface of the femalenon-luer connector may have a 5% taper that decreases in a proximal todistal direction. In one or more alternative embodiments, the non-luerelement further includes at least one aperture that provides access tothe channel.

A third aspect of the present invention pertains to a drug deliverydevice that includes a container and a female non-luer connector. In oneor more embodiments, the container includes an open distal end includinga distal wall and a sidewall extending in the proximal direction fromthe distal wall. The sidewall includes an inside surface defining afluid chamber for retaining fluids. An elongate tip is disposed on thedistal wall and extends in a distal direction from the distal wall. Theelongate tip includes an opening for providing access to the chamber andan inside surface including a taper of less than 6% decreasing in aproximal to distal direction. The elongate tip may have an outercross-sectional dimension sized to prevent connection of a standardfemale luer connector to the container. The female non-luer connectormay include a hub body including an open proximal end and an interiorsurface defining a cavity. The interior surface of the hub body may havea taper of less than 6% decreasing in a proximal to distal direction.The cavity may have an inner cross-sectional dimension that is sized toprevent connection of the female non-luer connector to a standard femaleluer connector. The hub body may optionally include a needle cannulaattached to the hub body that includes an open distal end in fluidcommunication with the opening of the container.

The drug delivery device of one or more embodiments may include a visualindicator for providing indication that a fluid-tight seal is formedbetween the female non-luer connector and the container and the needlecannula is in fluid communication with the opening of the container.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a perspective view of the syringe barrel having a standardmale luer connector according to the prior art;

FIG. 2 illustrates a cross-sectional side view of the syringe barrel andstandard male luer connector of FIG. 1;

FIG. 3 illustrates an enlarged view of the standard male luer connectorof FIG. 2;

FIG. 4 illustrates a cross-sectional side view of a needle hub having astandard female luer connector according to the prior art;

FIG. 5 illustrates a perspective view of a female non-luer connectoraccording to one or more embodiments of the present invention;

FIG. 6 illustrates a perspective view from a proximal end of thenon-luer hub shown in FIG. 5;

FIG. 7 illustrates a side elevational view of the female non-luerconnector shown in FIG. 5;

FIG. 8 illustrates a side elevational view of the female non-luerconnector shown in FIG. 7, after rotating the connector 90 degrees;

FIG. 9 illustrates a front elevational view of the female non-luerconnector shown in FIG. 7;

FIG. 10 illustrates a rear elevational view of the female non-luerconnector shown in FIG. 7;

FIG. 11 illustrates a cross-sectional view of the female non-luerconnector shown in FIG. 7 taken along line 11-11;

FIG. 12 illustrates a perspective view of the female non-luer connectorshown in FIG. 11 taken from the proximal end;

FIG. 13 shows a perspective view of the female non-luer connector shownin FIG. 11 taken from the distal end;

FIG. 14 illustrates a perspective view from a proximal end of acontainer according to one or more embodiments of the present invention;

FIG. 15 illustrates a perspective view from a distal end of thecontainer shown in FIG. 14;

FIG. 16 illustrates a side elevational view of the container shown inFIG. 14;

FIG. 17 illustrates a side elevational view of the container shown inFIG. 16, after rotating the container 90 degrees;

FIG. 18 illustrates a rear elevational view of the container shown inFIG. 16;

FIG. 19 illustrates a front elevational view of the container shown inFIG. 16;

FIG. 20 illustrates a cross-sectional view of the container shown inFIG. 17 taken along line 20-20;

FIG. 21 illustrates a perspective view of the container shown in FIG. 17taken from the proximal end;

FIG. 22 shows a perspective view of the container shown in FIG. 17 takenfrom the distal end;

FIG. 23 illustrates a perspective view from a distal end of a containeraccording to one or more embodiments of the present invention;

FIG. 24 illustrates a rear elevational view of the container shown inFIG. 23;

FIG. 25 illustrates a front elevational view of the container shown inFIG. 23;

FIG. 26 illustrates an enlarged partial cross-sectional view of thecontainer shown in FIG. 23 taken along line 26-26;

FIG. 27 illustrates a perspective view of the container shown in FIG. 26taken from the proximal end;

FIG. 28 shows a perspective view of the container shown in FIG. 26 takenfrom the distal end;

FIG. 29A illustrates a partial perspective view from a distal end of acontainer according to one or more embodiments of the present invention;

FIG. 29B illustrates a partial perspective view from a distal end of acontainer according to one or more embodiments of the present invention;

FIG. 29C illustrates a partial perspective view from a distal end of acontainer according to one or more embodiments of the present invention;

FIG. 29D illustrates a partial perspective view from a distal end of acontainer according to one or more embodiments of the present invention;

FIG. 29E illustrates a partial perspective view from a distal end of acontainer according to one or more embodiments of the present invention;

FIG. 30 illustrates a rear elevational view of the container shown inFIG. 29;

FIG. 31 illustrates a front elevational view of the container shown inFIG. 29;

FIG. 32 illustrates an enlarged partial cross-sectional view of thecontainer shown in FIG. 29 taken along line 32-32;

FIG. 33 illustrates a perspective view of the container shown in FIG. 37taken from the proximal end;

FIG. 34 illustrates a partial enlarged view of the distal end containerof FIG. 33;

FIG. 35 illustrates a partial perspective view from a distal end of acontainer according to one or more embodiments of the present invention;

FIG. 36 illustrates a partial side elevational view of the containershown in FIG. 35;

FIG. 37 illustrates a rear elevational view of the container shown inFIG. 35;

FIG. 38 illustrates a front elevational view of the container shown inFIG. 35;

FIG. 39 illustrates an enlarged partial cross-sectional view of thecontainer shown in FIG. 36 taken along line 39-39;

FIG. 40 illustrates a perspective view of the container shown in FIG. 39taken from the proximal end;

FIG. 41 shows a perspective view of the container shown in FIG. 39 takenfrom the distal end;

FIG. 42 illustrates a perspective view of a container according to oneor more embodiments of the present invention;

FIG. 43 illustrates an enlarged partial side elevational view of thecontainer shown in FIG. 42;

FIG. 44 illustrates a side elevational view of the container shown inFIG. 43, after rotating the container 90 degrees;

FIG. 45 illustrates a rear elevational view of the container shown inFIG. 42;

FIG. 46 illustrates a front elevational view of the container shown inFIG. 42;

FIG. 47 illustrates a cross-sectional view of the container shown inFIG. 44 taken along line 47-47;

FIG. 48 shows a perspective view of the container shown in FIG. 47 takenfrom the distal end;

FIG. 49 illustrates an enlarged partial perspective view from a distalend of a container according to one or more embodiments of the presentinvention;

FIG. 50 illustrates an enlarged partial side elevational view of thecontainer shown in FIG. 49;

FIG. 51 illustrates a side elevational view of the container shown inFIG. 50, after rotating the container 90 degrees;

FIG. 52 illustrates a rear elevational view of the container shown inFIG. 50;

FIG. 53 illustrates a front elevational view of the container shown inFIG. 50;

FIG. 54 illustrates a cross-sectional view of the container shown inFIG. 50 taken along line 54-54;

FIG. 55 illustrates a perspective view of the container shown in FIG. 54taken from the proximal end;

FIG. 56 shows a perspective view of the container shown in FIG. 54 takenfrom the distal end;

FIG. 57 illustrates an enlarged partial perspective view from a distalend of a container according to one or more embodiments of the presentinvention;

FIG. 58 illustrates a side elevational view of the container shown inFIG. 57;

FIG. 59 illustrates a rear elevational view of the container shown inFIG. 57;

FIG. 60 illustrates a front elevational view of the container shown inFIG. 57;

FIG. 61 illustrates an enlarged partial cross-sectional view of thecontainer shown in FIG. 58 taken along line 61-61;

FIG. 62 shows an enlarged partial perspective view of the containershown in FIG. 61 taken from the distal end;

FIG. 63 illustrates an enlarged partial view of the tip of the containershown in FIG. 62; and

FIG. 64 show chart comparing the existing ISO standard for standard luerconnectors according to the prior art and the proposed standard for maleand female connectors for neuraxial applications.

DETAILED DESCRIPTION

Before describing several exemplary embodiments of the invention, it isto be understood that the invention is not limited to the details ofconstruction or process steps set forth in the following description.The invention is capable of other embodiments and of being practiced orbeing carried out in various ways.

Aspects of the present invention pertain to non-luer connectors thatprevent misconnection to other incompatible or unintended standard luerconnectors. A non-luer connector shall be defined herein as a connectorthat has a shape, dimension or structure that differs from standard luerconnectors, as defined above. A non-luer connector shall also include aconnector that has a shape, dimension or structure that prevents it frombeing characterized or defined as a luer connector as defined above oraccording ISO 594-1:1986 or ISO 594-2:1998. In one or more specificembodiments, a non-luer connector has a length and/or cross-sectionaldimension that differs from a luer connector as defined above oraccording ISO 594-1:1986 or ISO 594-2:1998. In a more specificembodiment, a non-luer connector has a taper that differs from a luerconnector as defined above or according ISO 594-1:1986 or ISO594-2:1998. In an even more specific embodiment, a non-luer connectorhas a more gentle taper than a luer connector as defined above oraccording ISO 594-1:1986 or ISO 594-2:1998, a cross-sectional dimensionthat is smaller than a luer connector as defined above or according ISO594-1:1986 or ISO 594-2:1998 and a longer length than a luer connectoras defined above or according ISO 594-1:1986 or ISO 594-2:1998.Specifically, the embodiments of the non-luer connectors describedherein incorporate features that prevent connection of standard luerconnectors to the non-luer connectors. Standard luer connectors, as usedherein, may include needle hubs, syringes or other delivery componentsthat incorporate a standard luer connector. Exemplary standard luerconnectors are shown in FIGS. 1-4. FIG. 1 illustrates a syringe barrel100 having distal end 111 and a proximal end 119. The syringe barrel 100includes a sidewall 112 that extends from the distal end 111 to theproximal end 119 and includes an inside surface 114 defining a chamber116 for retaining fluids. The syringe barrel 100 also includes a distalwall 118 adjacent to the distal end 111 and a flange 120 disposed at theproximal end 119 of the syringe barrel. A luer connector 121 is providedin the form of an open tip 122 that extends from the distal wall 118 andincludes a passageway 124 in fluid communication with the chamber 116.The tip 122 includes an outside surface 126 that defines an outercross-sectional dimension and length that is typical of standard maleluer connectors.

An exemplary standard needle hub 130 having a standard female luerconnector is shown in FIG. 4. The needle hub 130 includes an open distalend 131 and an open proximal end 139. A hub body 132 extends from thedistal end 131 to the proximal end 139. In the embodiment shown, theluer connector 133 is provided in the form of a hub body 132 thatincludes an inside surface 134 defining a cavity 136. The cavity 136 issized and has a shape to permit fluid-tight engagement with the tip 122of the syringe barrel. The needle hub 130 shown in FIG. 4 also includesa needle cannula 140 attached to the open distal end 111. The needlecannula 140 includes an open distal end 142 in fluid communication withthe cavity 136. The inside surface 134 of the hub body 132 has an innercross-sectional dimension and length that is typical of standard femaleluer connectors.

Both of the standard luer connectors of the syringe barrel 100 and theneedle hub 130 are sized and shaped form an interference fit connectionand/or fluid-tight engagement with each other. Specifically, the outsidesurface of the tip 122 has a taper, length and shape that is typical ofstandard male luer connectors, as described above, that permits the tip122 to form an interference fit connection with the inside surface ofthe needle hub 130, which also has a taper, length and shape that istypical of standard female luer connectors, as also described above. Inone or more alternative embodiments, the syringe barrel 100 may includea standard male luer connector in the form of a luer lock connector (notshown), which includes a threaded portion that engages a cooperatingstructure of the needle hub 130, for example, as shown in FIG. 4, theoutwardly extending tab 138, to attach the needle hub 130 to the syringebarrel 100.

A first aspect of the present invention pertains to non-luer connectorswhich have a dimension and/or shape or incorporate a feature thatprevent connection of the non-luer connectors to standard luerconnectors. A second aspect of the present invention includes non-luerconnectors that utilize a non-luer element to prevent connection tostandard luer connectors. A third aspect of the present inventionincludes non-luer connectors that prevent the formation of a fluid-tightconnection between the non-luer connectors and a standard luer connectorthereby causing leakage or increasing the possibility of leakage ofliquid at the connection.

One or more embodiments of a female non-luer connector 200 are shown inFIGS. 5-13 that may be utilized as part of the drug delivery devicesaccording to the first aspect, second aspect and the third aspects ofthe present invention. Specifically, the female non-luer connector 200includes a non-luer portion 230 that may be connected to a non-luerconnector of the containers that will be described below.

The female non-luer connector 200 includes an open distal end 201 and anopen proximal end 209. The female non-luer connector 200 also includes anon-luer portion 230 for forming an interference fit connection with acorresponding non-luer connector. The non-luer portion 230 is anintegral component of the female non-luer connector 200 and is providedin the embodiment shown in FIGS. 5-13 as a wall 212 that extendsdistally from the open proximal end 209 of the female non-luer connector200. The wall 212 includes an inside surface 214 defining a cavity 216for receiving at least a portion of a corresponding non-luer connector.The female non-luer connector 200 includes an outside surface 203 with aradially outwardly extending rim 218 is disposed along the entirecircumference of the outside surface 203 at the distal end 201 of thefemale non-luer connector 200. The rim 218 in the embodiment shown inFIGS. 5-13 includes a radially outwardly extending tab 220 disposedalong at least a portion of the rim 218 for engaging correspondingnon-luer connectors with a locking feature or threaded component. Thetab 220 may include two tapered ends for facilitating engagement withthe locking feature or threaded component. The rim 218 includes aninside surface 219 that has a cross-sectional diameter that is greaterthan the cross-sectional diameter of the remainder of the femalenon-luer connector 200.

The inside surface 214 of the wall 212 that has a dimension and/or shapethat enables engagement or attachment of the female non-luer connector200 with other corresponding non-luer connectors. As will be describedbelow, corresponding non-luer connectors include an outside surface withan outer cross-sectional dimension that is smaller or larger than theinner cross-sectional dimension measured at the inside surface 134 ofstandard female luer connectors. The outer cross-sectional dimension ofthe corresponding non-luer connectors, however, is sized and/or shapedto properly engage the inside surface 214 of the female non-luerconnector 200 shown in FIGS. 5-13 to produce a fluid-tight connection.

In one or more embodiments, the inside surface 214 of the wall 212 maybe shaped to form a fluid-tight engagement with a corresponding non-luerconnector having a non-circular cross-section. Specifically, the insidesurface 214 of the wall 212 may have a square, triangular or othernon-circular cross-section that permits the formation of an interferencefit connection and/or fluid-tight engagement with a non-luer connectorwith an outside surface having a square, triangular or othernon-circular cross-section.

In addition, the inside surface 214 of the wall 212 has a dimensionand/or shape that prevents engagement of the female non-luer connector200 to a standard male luer connector. Specifically, the inside surface214 of the wall 212 may have a square, triangular or other non-circularcross-section that prevents the formation of an interference fitconnection and/or fluid-tight engagement with a standard male luerconnector, for example, the tip 122 having an outside surface 126 with acircular cross-section. In embodiments where the inner cross-sectionaldimension of the wall 212 is sized to permit the tip 122 or standardmale connector of a typical luer connector to be disposed within thecavity 216, the non-circular cross-sectional shape of the wall 212 atthe inside surface 214 prevents sufficient contact between the outsidesurface 126 of the tip and, thereby, prevents formation of aninterference fit connection and/or fluid-tight engagement there between.In one or more embodiments, the inner cross-sectional dimension of thewall 212 may be greater than the outer cross-sectional dimension of thetip 122 or other standard male luer connector, which also preventssufficient contact between the outside surface 126 of the tip or otherluer connector and, thereby, prevents formation of an interference fitconnection and/or fluid-tight engagement there between.

In the embodiment shown, the attachment end 210 also includes a firstnarrowed wall 222 extending from the wall 212 to a second narrowed wall224 disposed distally adjacent to the first narrowed wall 222. A thirdnarrowed wall 226 is disposed distally adjacent to the second narrowedwall 224 and extends to the proximal end 209 of the female non-luerconnector 200. The inner cross-sectional dimension of the first narrowedwall 222 is less than the inner cross-sectional dimension of the wall212 measured at its inside surface. The first narrowed wall 222 may havea taper or an inner cross-sectional dimension that decreases in thedistal direction. The inner cross-sectional dimension or shape of thefirst narrowed wall 222 may also prevent attachment of the femalenon-luer connector 200 to a standard male luer connector.

The second narrowed wall 224 has an inner cross-sectional dimension thatis less than the inner cross-sectional dimension of the first narrowedwall 222 and the inner cross-sectional dimension of the wall 212. Asshown in FIG. 11, the second narrowed wall 224 may have a taper whereinits inner cross-sectional dimension decreases in the distal direction.In the embodiment shown in FIG. 11, the taper or decrease in the innercross-sectional dimension of the second narrowed wall 224 is severe ordrastic. In one or more alternative embodiments, the taper or decreasein the inner cross-sectional dimension of the second narrowed wall 224may be gradual and/or the second narrowed portion may have a constantinner cross-sectional dimension. The third narrowed wall 226 has aninner cross-sectional dimension that is less than the innercross-sectional dimensions of the wall 212, the first narrowed wall 222and the second narrowed wall 224. The third narrowed wall 226 may have aconstant inner cross-sectional dimension or, as shown in FIG. 11,include a proximal portion with a tapered inner cross-sectionaldimension that decreases in the distal direction and a distal portionwith a constant inner cross-sectional dimension. The third narrowed wall226 is shaped and sized to support a needle cannula within the cavity216, which extends from the open proximal end 209 of the female non-luerconnector to the open distal end of the hub, including from the wall 212to the third narrowed wall 226.

In one or more embodiments, the cavity 216 has an inner cross-sectionaldimension measured at the proximal end 209 of less than 0.168 inches. Inone or more specific embodiments, the cavity 216 has an innercross-section dimension measured at the proximal end 209 in the rangefrom about 0.100 inches to about 0.1600 inches, or more specifically inthe range from about 0.1300 inches to about 0.1500 inches. In an evenmore specific embodiment, the cavity 216 has an inner cross-sectiondimension measured at the proximal end 209 in the range from about0.1417 inches to about 0.1437 inches. The lower limit of the innercross-sectional dimension of the cavity 216 at the proximal end 209 mayinclude 0.1400 inches, 0.1404 inches, 0.1408 inches, 0.1412 inches and0.1416 inches. The upper limit of the inner cross-sectional dimension ofthe cavity 216 at the proximal end 209 may include 0.1439 inches, 0.1443inches, 0.1447 inches, 0.1451 inches and 0.1455 inches. In one or moreembodiments, the inner cross-sectional dimension of the cavity 216 maybe in the range from about 0.100 inches to 0.119 inches, from about0.130 inches to about 0.139 inches, from about 0.140 inches to about0.149 inches, from about 0.150 inches to about 0.159 inches, or fromabout 0.159 inches to about 0.167 inches.

In one or more embodiments, the inside surface 214 of the wall 212 mayhave a taper of less than 6% decreasing in a proximal to distaldirection or an inner cross-section dimension that decreases from theproximal end 209 toward the distal end 201 at a rate of less than 6%. Inone or more specific embodiments, the inside surface 214 of the wall 212has a taper decreasing in a proximal to distal direction in the rangefrom about 3% to about 5.9%. In one or more embodiments, the taper ofthe inside surface 214 of the wall 212 may be in the range from about0.5% to about 2.9% decreasing in a proximal to distal direction. In aspecific embodiment, the taper of the inside surface 214 of the wall 212is about 5% decreasing in a proximal to distal direction. The lowerlimit of the taper of the inside surface 214 of the wall 212 decreasingin a proximal to distal direction may include 4.2%, 4.4%, 4.6%, 4.8%.The upper limit of the taper of the inside surface 214 of the wall 212decreasing in a proximal to distal direction may include 5.2%, 5.4%,5.6%, 5.8%. In one or more embodiments, the inside surface 214 of thewall 212 may have a taper of more than 6% decreasing in a proximal todistal direction or an inner cross-section dimension that decreases fromthe proximal end 209 toward the distal end 201 at a rate of more than6%.

In one or more embodiments, the length of the cavity 216 measured fromthe proximal end 209 to the end of the second narrowed wall 224, but notincluding the second narrowed wall, may be in the range from about 0.200inches to about 0.500 inches. In a more specific embodiment, the lengthof the cavity 216 from the proximal end 209 to the end of the secondnarrowed wall 224, but not including the second narrowed wall 224, maybe in the range from about 0.295 inches to about 0.400 inches. In aneven more specific embodiment, the length of the cavity 216 may be about0.303 inches.

The outside surface 203 of the female non-luer connector includes atleast one arm that extends from the first narrowed wall 222 to alocation adjacent to the open distal end 201 of the hub. In theembodiment shown in FIGS. 5-13, the female non-luer connector 200includes two arms 231, 232 that are disposed on opposite sides of thefemale non-luer connector 200 and extend from the first narrowed wall222 to a location adjacent to the open distal end 201. The arms 231, 232define spaces 234, 236 between the outside surface 203 of the femalenon-luer connector and the arms 231, 232. The arms 231, 232 provide afinger grip area or a gripping surface on which to grasp the femalenon-luer connector 200 during use. The arms 231, 232 may have any shapeknown to provide such a finger grip area. In one or more alternativeembodiments, the female non-luer connector 200 may be free of anystructure on its outside surface 203.

Adjacent to the open distal end 201, the female non-luer connectorincludes an annular disc 240 disposed adjacent to the two arms 231, 232that extends radially outwardly from the outside surface 203 of the hub.Four discrete protrusions 243, 244, 245, 246 extend radially outwardlyfrom the outside surface 203 and extend from the annular disc 240 to theopen distal end 201 along the same axis. The four discrete protrusions243, 244, 245, 246 are located along the third narrowed wall 222, asshown in FIGS. 11 and 12.

As shown more clearly in FIG. 6, the rim 218 may include an indentationfor use with a stylet and a spinal needle. In one or more alternativeembodiments, the indentation provides a needle bevel orientationindicator in which the indentation is aligned with the bevel of a needlecannula.

One or more embodiments of a non-luer connector for use in a drugdelivery device according to the first aspect of the present inventionare shown in FIGS. 14-22. FIGS. 14-22 illustrate a non-luer connector300 that includes a non-luer portion 330 for attachment to anothernon-luer connector, for example, the female non-luer connector 200described above. The non-luer connector 300 of FIGS. 14-22 is shownintegrally formed to a container in the form of a syringe barrel 310.The container may be provided in other forms, for example, a drug bag,an epidural pump and other containers known in the art. The syringebarrel 310 shown in FIGS. 14-22 includes a distal end 311, an openproximal end 319 and a sidewall 312 extending between the distal end 311to the open proximal end 319. The sidewall 312 includes an insidesurface 314 that defines a chamber 316 for retaining fluids, which mayinclude liquid medication and/or other liquids. The open proximal end319 may include an option flange 320 and the distal end 311 includes adistal wall 318. The non-luer portion 330 is integrally formed orprovided in the container. Specifically, in the embodiment shown inFIGS. 14-22, the non-luer portion 330 is provided in the form of a tip332 that extends in the distal direction from the distal wall 318 andincludes an opening 334. The tip 332 extends from the distal wall 318 toa distal end 333 of the tip. The tip 332 includes an outside surface 338and an inside surface 340 that defines a passageway 342 permitting fluidcommunication between the chamber 316 and the opening 334.

In the embodiment shown, the tip 332 has a dimension and/or shape thatprevent the connection of a standard female luer connector, for example,the needle hub 130 shown in FIG. 4, to the syringe barrel 310.Specifically, the non-luer portion 330 has a square cross-section and/oran outer cross-sectional dimension that is not compatible with typicalluer connectors which have a circular cross-section and/or smaller orlarger outer cross-sectional dimension. In the embodiment shown, the tip332 is shown in the form of four discrete walls 343, 344, 345, 346 thatare connected to form an enclosure around the passageway 342 of the tip332 having a square cross-section. In one or more embodiments, the outercross-sectional dimension of the tip 332, measured from the outsidesurface 338 of the tip 332 at the intersection of walls 343 and 346 andthe intersection of walls 345 and 344 is greater than the innercross-sectional dimension of the inside surface 134 of the hub body 132of luer connector 133 of the needle hub 130. Accordingly, the hub body132 cannot fit or slide over the tip 332 such that the tip 332 isdisposed within the cavity 136 and the inside surface 134 of the hubbody 132 cannot form an interference fit connection and/or fluid-tightengagement with the outside surface 338 of the tip 332. Accordingly, thenon-luer portion 330 prevents connection of a standard female luerconnector, for example, the luer connector 133 of needle hub 130. Aswill be described below, the non-luer portion 330 has a dimension and/orshape that permit connection to another corresponding non-luerconnector.

In one or more alternative embodiments, the tip 332 may have an outercross-sectional dimension that is smaller than the inner cross-sectionaldimension of a standard female luer connector. In such embodiments, thesmaller outer cross-sectional dimension of the tip 332 preventssufficient contact between the inside surface 134 of the luer connectorand the outside surface 338 of the tip to form an interference fitconnection and/or fluid-tight engagement there between.

In one or more embodiments, even if the inside surface 134 of the hubbody 132 had a inner cross-sectional dimension large enough to permitthe hub body 132 to slide over the outside surface 338 of the tip 332such that the tip 332 is disposed within the cavity 136, the squarecross-section of the tip 332 prevents the inside surface 134 of the hubbody 132 from having sufficient contact with the outside surface 338 ofthe tip 332 to form an interference fit connection and/or a fluid-tightseal with the outside surface 338 of the tip 332. This is because theinside surface 134 is curved and would not contact the outside surface338 of the tip 332. In other words, the corners of the tip 332 having asquare cross-section would not be in contact with the inside surface ofa hub with a circular cross-section, for example needle hub 130. In oneor more alternative embodiments, the tip 332 may have a triangularcross-section, or other cross-section that prevents sufficient contactwith the inside surface of a standard female luer connector, for examplethe inside surface 134 of luer connector 133, thereby preventing theformation of an interference fit connection and/or fluid-tight sealthere between.

The tip 332 may also have a length that prevents formation of aninterference fit connection and/or fluid-tight engagement with astandard female luer connector. Specifically, the length of the tip 332may be too long or too short to permit the respective taper of the tip332 and the inside surface 134 of the luer connector to align to form aninterference fit connection and/or fluid-tight engagement there between.

In one or more embodiments, the tip 332 has an outer cross-sectionaldimension of 0.1545 inches or less at the distal end 333. In a morespecific embodiment, the tip 332 has an outer cross-sectional dimensionin the range from about 0.1200 inches to about 0.1500 inches at thedistal end 333, or more specifically, in the range from about 0.1300inches to about 0.1400 inches. In an even more specific embodiment, thetip 332 may have an outer cross-sectional dimension at the distal end333 in the range from about 0.1306 inches to about 0.1326 inches. In oneor more specific embodiments, the outer cross-sectional dimension of thetip 332 at the distal end 333 is in the range from about 0.100 inches toabout 0.119 inches, from about 0.120 inches to about 0.129 inches, fromabout 0.130 inches to about 0.139 inches, from about 0.140 inches toabout 0.149 inches, or from about 0.150 inches to about 0.154 inches.The upper limit of the outer cross-sectional dimension of the tip 332 atthe distal end 333 may include 0.1328 inches, 0.1330 inches, 0.1332inches, 0.13334 inches, 0.1336 inches and 0.1338 inches. The lower limitof the outer cross-sectional dimension of the tip 332 at the distal end333 may include 0.1304 inches, 0.1302 inches, 0.1298 inches, 0.1296inches, 0.1294 inches, 0.1292 inches and 0.1290 inches.

In one or more embodiments, the outside surface 338 of the tip 332 mayhave a taper of less than 6% decreasing in a proximal to distaldirection or an outer cross-sectional dimension that decreases in aproximal to distal direction at a rate of less than 6%. In one or morespecific embodiments, the outside surface 338 of the tip 332 may have ataper decreasing in a proximal to distal direction in the range fromabout 3% to about 5.9% or from about 0.5% to about 2.9%. In a specificembodiment, the outside surface 338 of the tip 332 has a 5% taperdecreasing in the proximal to distal direction.

In one or more embodiments, the outside surface 338 of the tip 332 mayhave a taper of more than 6% decreasing in a proximal to distaldirection or an outer cross-sectional dimension that decreases in aproximal to distal direction at a rate of more than 6%.

In one or more embodiments, the length of the tip 332 from the distalwall 318 to the distal end 333 of the tip may be in the range from about0.200 inches to about 0.500 inches. In one or more specific embodiments,the length of the tip 332 may be in the range from about 0.250 inches toabout 0.450 inches, or more specifically, in the range from about 0.295inches to about 0.400 inches. In an even more specific embodiment, thelength of the tip 332 may be about 0.300 inches.

In use with a corresponding non-luer connector, for example, the femalenon-luer connector 200 of FIGS. 5-13, the tip 332 is inserted into thecavity 216 of the female non-luer connector 200. A force is applied tothe syringe barrel 310 in the distal direction and/or to the femalenon-luer connector 200 in the proximal direction to cause the insidesurface 214 of the wall 212 of the female non-luer connector to engagethe outside surface 338 of the tip 332 in an interference fit connectionand/or fluid-tight engagement. To remove the female non-luer connector200 from the syringe barrel 310, a force is applied to the container inthe proximal direction and/or to the female non-luer connector 200 inthe distal direction to disengage the interference fit connection and/orthe fluid-tight engagement of there between.

FIGS. 23-28 illustrate another embodiment of a non-luer connector 400for use in a drug delivery device according to the first aspect of thepresent invention. Specifically, FIGS. 23-28 illustrate a non-luerconnector 400 that includes a non-luer portion 430 for attachment to anon-luer connector, for example, the female non-luer connector 200described above. The non-luer connector 400 is shown integrally formedto a container in the form of a syringe barrel 410, as described abovewith reference to FIGS. 14-22. As mentioned above with respect to FIGS.14-22, the container may be provided in other forms, for example, a drugbag, an epidural pump and other containers known in the art. The syringebarrel 410 shown in FIGS. 23-28 includes a distal wall 418. The non-luerportion 430 is integrally formed or provided in the container.Specifically, in the embodiment shown in FIGS. 23-28, the non-luerportion 430 is provided in the form of a tip 432 that extends in thedistal direction from a distal wall 418 of the syringe barrel 410 andincludes an opening 434. The tip 432 includes a body wall 436 thatextends from the distal wall 418 to a distal end 433 of the tip. Thebody wall 436 that includes an outside surface 438 and an inside surface440 that define a passageway 442 permitting fluid communication betweenthe chamber of the syringe barrel 410 and the opening 434. The distalend 433 of the tip 432 also includes an end wall 444 that extendsinwardly from the outside surface 438 of the body wall 436 to theopening 434.

In the embodiment shown, the body wall 436 has a dimension and/or shapethat prevent the connection of a standard female luer connector, forexample, the needle hub 130 shown in FIG. 4, to the syringe barrel 410.Specifically, the body wall 436 of the non-luer portion 430 has an outercross-sectional dimension and/or a thickness that is not compatible withtypical luer connectors, which have smaller or larger innercross-sectional dimension. In the embodiment shown, the body wall 436 isshown in the form of a continuous wall having a circular cross-sectionthat forms an enclosure around the passageway 442 of the tip 432 havinga square cross-section. In one or more embodiments, the outercross-sectional dimension of the body wall 436 at the outside surface438 is greater than the inner cross-sectional dimension of the insidesurface 134 of the hub body 132 of luer connector 133 of the needle hub.Accordingly, the hub body 132 cannot fit or slide over the body wall 436such that the tip 432 is disposed within the cavity 136 and the insidesurface 134 of the hub body 132 cannot form an interference fitconnection and/or fluid-tight engagement with the outside surface 438 ofthe body wall 436. Accordingly, the non-luer portion 430 preventsconnection of a standard female luer connector, for example, needle hub130. As will be described below, the non-luer portion 430 has an outercross-sectional dimension that permits connection to anothercorresponding non-luer connector.

The thickness of the body wall 436 may also have a dimension thatprevents connection of a standard female luer connector to the non-luerconnector 430. Specifically, the body wall 436 may have a thickness thatincreases the outer cross-sectional dimension of the tip 432, which, asdiscussed above, prevents formation of an interference fit connectionand/or fluid-tight engagement of with a standard female luer connector.The thickness of the body wall 436 may also be modified by decreasingthe cross-sectional dimension of the passageway 442 and maintaining theouter cross-sectional dimension of the tip 432.

In one or more alternative embodiments, the tip 432 may have an outercross-sectional dimension that is smaller than the inner cross-sectionaldimension of a standard female luer connector, for example, the luerconnector 133 of needle hub 130, shown in FIG. 4. In such embodiments,the smaller outer cross-sectional dimension of the body wall 436prevents sufficient contact between the inside surface 134 of the luerconnector and the outside surface 438 of the body wall to form ainterference fit connection and/or fluid-tight engagement there between.The non-luer portion 430 or the tip 432 may also have a length thatprevents formation of an interference fit connection and/or fluid-tightengagement with a standard female luer connector, for example the luerconnector 133 of FIG. 4. Specifically, the length of the body wall 436may be too long or too short to permit the respective taper of the bodywall 436 and the inside surface 134 of the luer connector to align toform an interference fit connection and/or fluid-tight engagement therebetween.

In one or more embodiments, the tip 432 has an outer cross-sectionaldimension of less than 0.1545 inches at the distal end 433 of the tip orat the end wall 444. It will be understood that the outercross-sectional dimension of the tip 432 includes the longest distancebetween two points on the outer surface 438 of the tip. In a morespecific embodiment, the tip 432 has an outer cross-sectional dimensionin the range from about 0.1200 inches to about 0.1500 inches, or morespecifically, in the range from about 0.1300 inches to about 0.1400inches at the distal end 433 of the tip or at the end wall 444. In aneven more specific embodiment, the tip 432 may have an outercross-sectional dimension in the range from about 0.1306 inches to about0.1326 inches at the end wall 444 or at the distal end of the tip. Inone or more specific embodiments, the outer cross-sectional dimension ofthe tip 432 at the end wall 444 or at the distal end 433 of the tip isin the range from about 0.100 inches to about 0.119 inches, from about0.120 inches to about 0.129 inches, from about 0.130 inches to about0.139 inches, from about 0.140 inches to about 0.149 inches, or fromabout 0.150 inches to about 0.154 inches. The upper limit of the outercross-sectional dimension of the tip 432 at the end wall 444 or distalend 433 of the tip may include 0.1328 inches, 0.1326 inches, 0.1330inches, 0.1332 inches, 0.13334 inches, 0.1336 inches and 0.1338 inches.The lower limit of the outer cross-sectional dimension of the tip 432 atthe end wall 444 or at the distal end 433 of the tip may include 0.1306inches, 0.1304 inches, 0.1302 inches, 0.1298 inches, 0.1296 inches,0.1294 inches, 0.1292 inches and 0.1290 inches.

In one or more embodiments, the outside surface 438 of the tip 432 mayhave a taper of less than 6% decreasing in a proximal to distaldirection or an outer cross-section dimension that decreases in aproximal to distal direction at a rate of less than 6%. In one or morespecific embodiments, the outside surface 438 of the tip 432 may have ataper decreasing in a proximal to distal direction in the range fromabout 3% to about 5.9% or from about 0.5% to about 2.9%. In a specificembodiment the outside surface 438 of the tip 432 may have a taper of 5%decreasing in the proximal to distal direction.

In one or more embodiments, the length of the tip 432 from the distalwall 418 to the distal end 433 of the tip or at the end wall 444 may bein the range from about 0.200 inches to about 0.500 inches. In one ormore specific embodiments, the length of the tip 432 from the distalwall 418 to the distal end 433 of the tip or at the end wall 444 may bein the range from about 0.250 inches to about 0.450 inches, or morespecifically, in the range from about 0.295 inches to about 0.400inches. In an even more specific embodiment, the length of the tip 432from the distal wall 418 to the distal end 433 of the tip or at the endwall 444 may be about 0.300 inches.

In use with a corresponding non-luer connector, for example, the femalenon-luer connector 200 of FIGS. 5-13, the tip 432 is inserted into thecavity 216 of the female non-luer connector 200. A force is applied tothe syringe barrel 410 in the distal direction and/or to the femalenon-luer connector 200 in the proximal direction to cause the insidesurface 214 of the wall 212 of the female non-luer connector to engagethe outside surface 438 of the tip 432 in an interference fit connectionand/or fluid-tight engagement. To remove the female non-luer connector200 from the syringe barrel 410, a force is applied to the container inthe proximal direction and/or to the female non-luer connector 200 inthe distal direction to disengage the interference fit connection and/orthe fluid-tight engagement of there between.

One or more embodiments of a non-luer connector 500 for use in a drugdelivery device according to the second aspect of the present inventionare shown in FIGS. 29-34. FIGS. 29-34 illustrate a non-luer connector500 that includes a non-luer element 550 that prevents attachment of astandard female luer connector, for example, needle hub 130 describedabove, thereto. The non-luer connector 500 of FIGS. 29-34 is shownintegrally formed to a container in the form of a syringe barrel 510, asdescribed above with reference to FIGS. 14-22. The container may beprovided in other forms, for example, a drug bag, epidural pump andother containers known in the art. The syringe barrel 510 shown in FIGS.29-34 includes a distal wall 518. A tip 532 extends in the distaldirection from a distal wall 518 of the syringe barrel 510 and includesa passageway 542 and an opening 534 in fluid communication with thechamber of the syringe barrel.

The outside surface 538 of the tip may have a dimension and/or shapethat forms an interference fit connection and/or fluid-tight engagementwith the inside surface of a corresponding non-luer connector. In one ormore embodiments, the outside surface 538 of the tip has a dimensionand/or shape that may permit a user to force an incorrect interferencefit connection and/or an incorrect fluid-tight engagement of thenon-luer connector 500 with a standard female luer connector. As will bedescribed below, the non-luer element prevents such incorrect connectionor engagement. In one or more embodiments, the outside surface 538 ofthe tip has a dimension and/or shape that prevents formation of aninterference fit connection and/or fluid-tight engagement with astandard female luer connector and, instead, permits such connectionand/or engagement with a corresponding non-luer connector.

In one or more embodiments, the tip 532 has an outer cross-sectionaldimension of less than 0.1545 inches, measured at a distal end 536 ofthe tip. In a more specific embodiment, the tip has an outercross-sectional dimension measured at the distal end 536 in the rangefrom about 0.1200 inches to about 0.1500 inches, or more specifically,in the range from about 0.1300 inches to about 0.1400 inches. In an evenmore specific embodiment, the tip may have an outer cross-sectionaldimension measured at the distal end 536 in the range from about 0.1306inches to about 0.1326 inches. In one or more specific embodiments, theouter cross-sectional dimension of the tip 532 measured at the distalend 536 is in the range from about 0.100 inches to about 0.119 inches,from about 0.120 inches to about 0.129 inches, from about 0.130 inchesto about 0.139 inches, from about 0.140 inches to about 0.149 inches, orfrom about 0.150 inches to about 0.154 inches. The upper limit of theouter cross-sectional dimension of the tip 532 measured at the distalend 536 may include 0.1328 inches, 0.1330 inches, 0.1332 inches, 0.13334inches, 0.1336 inches, 0.1314 inches and 0.1338 inches. The lower limitof the outer cross-sectional dimension of the tip 532 measured at thedistal end 536 may include 0.1304 inches, 0.1307 inches, 0.1302 inches,0.1298 inches, 0.1296 inches, 0.1294 inches, 0.1292 inches and 0.1290inches.

In one or more embodiments, the outside surface 538 of the tip 532 mayhave a taper of less than 6% decreasing in a proximal to distaldirection or an outer cross-section dimension that decreases in aproximal to distal direction at a rate of less than 6%. In one or morespecific embodiments, the outside surface 538 of the tip 532 may have ataper decreasing in a proximal to distal direction in the range fromabout 3% to about 5.9% or from about 0.5% to about 2.9%. In a specificembodiment, the outside surface 538 of the tip 532 has a 5% taperdecreasing in a proximal to distal direction.

In one or more embodiments, the length of the tip 532 from the distalwall 518 to the distal end 536 of the tip may be in the range from about0.200 inches to about 0.500 inches. In one or more specific embodiments,the length of the tip 532 from the distal wall 518 to the distal end 536of the tip may be in the range from about 0.250 inches to about 0.450inches, or more specifically, in the range from about 0.295 inches toabout 0.400 inches. In an even more specific embodiment, the length ofthe tip 532 from the distal wall 518 to the distal end 536 of the tipmay be about 0.300 inches.

The non-luer element 550 is integrally formed or provided in thecontainer. Specifically, in the embodiment shown in FIGS. 29-34, thenon-luer element 550 is integrally formed and disposed on the distalwall 518 of the syringe barrel and extends in the distal direction in acoaxial relationship with the tip 532. The non-luer element 550 forms achannel 560 between the tip 532 and the non-luer element 550. In theembodiment shown, the non-luer element 550 is shown as a plurality ofbarrier walls 552 that extend from the distal wall 518 in the distaldirection. The barrier wall 552 includes a free or unattached distal end558 and a proximal end 559. The barrier wall 552 may be described ascantilevered with respect to the distal wall 518.

The barrier wall 552 includes an inside surface 554 that faces thechannel 560 and an outside surface 556. In the embodiment shown, thebarrier wall 552 has a length that is equal to the length of the tip532. In one or more alternative embodiments, the length of the barrierwall 552 may be less than or greater than the length of the tip 532.When the length of the barrier wall 552 is less than the length of thetip 532, it should not be so short that it fails to prevent the userfrom forcing an incorrect connection with a standard female luerconnector. That is, the length of the barrier wall 552 is stillsufficient to prevent such an incorrect connection. The length of thebarrier wall 552 when it is longer than the tip 532 is not particularlylimited except by practical considerations related to ease ofmanufacturing and ease of use. In one or more embodiments, thedifference between the length of the barrier wall 552 and the length ofthe tip 532 is less than about 0.070 inches. In one or more specificembodiments, the difference between the length of the barrier wall 552and the length of the tip 532 is in the range from about 0.00 inches toabout 0.050 inches or from about 0.051 inches to about 0.070 inches.

The inside surface 554 of the barrier wall 552 may have a plurality ofthreads disposed thereon for engaging a corresponding structure of anon-luer connector. For example, when female non-luer connector 200 isattached to the non-luer connector 500, the tab 220 disposed on theoutside surface 203 of the female non-luer connector engages theplurality of threads disposed on the inside surface 554 of the barrierwall 552. Engagement between the plurality of threads and the tab 220 isachieved by rotating the syringe barrel 510 and/or the non-luerconnector 500 with respect to the female non-luer connector 200.

The barrier wall 552 of the embodiment shown in FIGS. 29-34 has across-section that has an outer cross-sectional dimension that is lessthan or equal to the inner cross-sectional dimension of a standardfemale luer connector, for example, the inner cross-sectional dimensionof the hub body 132, of FIG. 4. The outer cross-sectional dimension ofthe barrier wall 552 may be sized to prevent the open proximal end ofthe luer connector, for example, the hub body 132 from entering thechannel 560 and engaging the outside surface 538 of the tip 532. In oneor more embodiments, the outer cross-sectional dimension of the barrierwall 552 may be less than the inner cross-sectional dimension of astandard luer connector and includes a feature that causes leakagebetween the standard luer connector and the barrier wall 552 when thestandard luer connector is attached to the barrier wall 552. In one ormore specific embodiments, the outer cross-sectional dimension of thebarrier wall 552 may have a shape to prevent a standard female luerconnector from entering the channel 560.

In one or more specific embodiments, the outer cross-sectional dimensionof the barrier wall may larger than 0.170 inches. In one or morealternative embodiments, the thickness of the barrier wall 552 may beadjusted such that the inner cross-sectional dimension of the barrierwall 552 is less than 0.170 inches or is otherwise sized to prevent thestandard female luer connector from entering the channel 560.

In embodiments in which the standard female luer connector incorporateslugs to engage a corresponding male luer lock connector, the outercross-sectional dimension of the barrier wall 552 may be greater thanabout 0.307 inches. In embodiments, in which the female luer connectordoes not incorporate lugs, the outer cross-sectional dimension of thebarrier wall 552 may be greater than about 0.224 inches.

In one or more embodiments, the outer cross-sectional dimension of thebarrier wall 552 is in the range from about 0.175 inches to about 0.500inches. In one or more specific embodiments, the outer cross-sectionaldimension of the barrier wall 552 may be in the range from about 0.175inches to about 0.264 inches, from about 0.265 inches to about 0.305inches, from about 0.305 inches to about 0.500 inches. The upper limitof the outer cross-sectional dimension of the barrier wall 552 mayinclude 0.300 inches, 0.302 inches, 0.304 inches, 0.306 inches, 0.308inches, 0.310 inches and 0.312 inches. The lower limit of the outercross-sectional dimension of the barrier wall may include 0.260 inches,0.262 inches, 0.264 inches, 0.266 inches, 0.268 inches and 0.270 inches.

In one or more embodiments, the barrier wall 552 has an innercross-sectional dimension in the range from about 0.200 inches to about0.305 inches. In one or more specific embodiments, the innercross-sectional dimension of the barrier wall 552 is in the range fromabout 0.200 inches to about 0.264 inches or from about 0.265 inches toabout 0.305 inches. The lower limit of the inner cross-sectionaldimension of the barrier wall 552 includes 0.260 inches, 0.262 inches,0.264 inches, 0.266 inches, 0.268 inches and 0.270 inches. The upperlimit of the outer cross-sectional dimension of the barrier wall 552includes 0.300 inches, 0.302 inches, 0.304 inches, 0.306 inches, 0.308inches, and 0.310 inches.

In one or more embodiments, as shown in FIGS. 29B and 29E, the non-luerelement 550 may be provided as a continuous and singular barrier wallthat extends continuously around the tip 532. In one or moreembodiments, as shown in FIG. 29B, the non-luer element 550 may beprovided as a uniform, continuous and singular barrier wall that extendscontinuously around the tip 532. In one or more embodiments, as shown inFIG. 29E, the non-luer element 550 may be provided as a continuous andsingular barrier wall being flush with tip 532 having one or more curvesor indentations that extends around the tip 532, where the tip 532 isvisible through the curve or indentation of the collar. In theembodiment shown in FIGS. 29A, 29C, 29 D and 30-34, the non-luer element550 is shown as a plurality of barrier walls 552 that form at least oneaperture 557 or a plurality of apertures spaced between the barrierwalls 552. In one or more embodiments, as shown in FIG. 29A, theapertures 557 of the embodiment shown extend from the distal end 558 tothe proximal end 559 of the barrier wall. In one or more alternativeembodiments, as shown in FIGS. 29 C and 29D, the apertures 557 mayextend from the distal end 558 to a distance between the distal end 558and the proximal end 559. In embodiments that incorporate apertures 557in the barrier wall, in the event a standard female luer connector isable to fit over the barrier wall 552 such that the inside surface ofthe luer connector is in contact with the outside surface 556 of thebarrier wall, the apertures 557 prevent or inhibit the formation of afluid-tight seal by providing openings to the exterior of the connectorthat will result in leakage of fluid delivered through the tip. In oneor more alternative embodiments, the aperture 557 provides visualindication of whether the non-luer element 550 functions similarly to aslip connector or a locking connector. In other words, the aperture 557provides visual indication of whether the non-luer element 550 includesa luer slip fitting or a luer lock fitting. Specifically, the presenceof the aperture 557 provides visual indication that the inside surface554 of the barrier wall 552 is free of a plurality of threads or otherlocking feature that cooperates to lock a corresponding non-luerconnector to the barrier wall 552. In one or more embodiments, theabsence of the aperture 557 provides visual indication that the insidesurface 554 of the barrier wall 552 includes a plurality of threads orother locking feature to lock a corresponding non-luer connector to thebarrier wall 552.

In the embodiment shown, the barrier wall 552 is shown in the form ofdiscrete walls that, when taken together, have a circular cross-sectionthat forms a partial enclosure around the tip 532 that also has acircular cross-section. In one or more embodiments, the barrier wall 552may have a triangular cross-section or other non-circular cross-section,which would prevent a standard female luer connector having a circularcross-section, for example the hub body 132 of FIGS. 1-3, from fittingor sliding within the channel 560 preventing the tip 532 and the insidesurface 134 of the hub body 132 from forming an interference fitconnection and/or fluid-tight engagement with the outside surface 538 ofthe tip 532. Accordingly, the non-luer element 550 prevents connectionof a standard female luer connector, for example, the luer connector 133of needle hub 130, to the syringe barrel 510.

In one or more alternative embodiments, the barrier wall 552 may have anouter cross-sectional dimension that is smaller than the innercross-sectional dimension of a standard female luer connector. In suchembodiments, the smaller outer cross-sectional dimension of the barrierwall 552 prevents sufficient contact between the inside surface 134 ofthe standard female luer connector and the outside surface 556 of thebarrier wall 552 to form a interference fit connection and/orfluid-tight engagement there between. The barrier wall 552 may also havea length that prevents formation of an interference fit connectionand/or fluid-tight engagement with a standard female luer connector, forexample the luer connector 133 shown in FIG. 4. Specifically, the lengthof the barrier wall 552 may be too long or too short to permitfluid-tight engagement with the inside surface 134 of the luer connector133.

As will be described below, the non-luer element 550 may have an outercross-sectional dimension that permits connection to anothercorresponding non-luer connector. For example, the female non-luerconnector 200 may have an exterior surface with an exteriorcross-sectional dimension sized to fit within the channel 560 such thatthe inside surface 214 forms an interference fit connection and/orfluid-tight engagement with the outside surface 538 of the tip.

As described above with reference to FIGS. 23-28, the non-luer element550 may also be utilized to prevent the user from forcing an incorrectinterference fit connection and/or fluid-tight engagement between thetip 532 and a standard female luer connector when the female luerconnector incorporates a soft or semi-rigid material, typically a rubberor elastomeric valve or seal. In such devices the rubber or elastomericvalve or seal may prevent the user from seeing leakage of the incorrectconnection between the male and female connectors because the valve orseal conforms to the size and shape of the non-luer connector, sealingleaking fluid within the female luer connector. Such valves or seals aretypically disposed within the hub cavity or on the inside surface of thehub cavity of standard female luer connectors. Standard female luerconnectors with such valves or seals may be referred to as soft luerconnectors or semi-rigid luer connectors. The valves or seals aretypically utilized to allow the inside surface or the cavity of thestandard female luer connector to conform to a variety of shapes. Thisprevents leakage between the male connector and the standard femaleconnector due to insufficient formation of a fluid-tight seal betweenthe standard female luer connector and a male connector. In suchembodiments, the outer surface 538 of the tip 532 could potentially beconnected to the standard female luer connector, with the valve or sealproviding a seal between the tip 532 and the standard female luerconnector. In one or more embodiments, the barrier wall 552 is shapedand/or sized to have inner cross-sectional dimension that preventsconnection of a standard female luer connector that includes a valve orseal, as described above, to the tip 532. Specifically, the innercross-sectional dimension of the barrier wall 552 is greater than theinner cross-sectional dimension of a standard female luer connector andless than the outer cross-sectional dimension of a standard female luerconnector. Accordingly, an attempt to connect the standard female luerconnector to the non-luer connector 500 will result in alignment of thehub body of the standard female luer connector with the barrier wall 552such that the barrier wall 552 will physically block the tip 532 frompenetrating the rubber or elastomeric valve or seal and thereforeprevent the hub body of the standard female luer connector fromattaching to the tip 532. Accordingly, the non-luer connector 500minimizes the risk that a user can utilize the non-luer connector 500described herein with an unintended standard female soft luer connector.

In use, to assemble the non-luer connector 500 to a correct,corresponding non-luer connector, for example, the female non-luerconnector 200 shown in FIGS. 5-13, the wall 212 is inserted into thechannel 560 between the barrier wall 552 and the tip 532 such that thetip 532 is disposed within the cavity 216. A force is applied in thedistal direction on the syringe barrel 510 until the outside surface 538of the tip engages the inside surface 214 of the wall of the femalenon-luer connector 200. In embodiments which utilize a threaded portionon the inside surface 554 of the barrier wall 552, the wall 212 of thefemale non-luer connector 200 is inserted into the channel 560 androtated with respect to the syringe barrel 510 such that the tab 220engages the threaded portion.

One or more embodiments of a non-luer connector 600 for use in a drugdelivery device according to the second aspect of the present inventionare shown in FIGS. 35-41. FIGS. 35-41 illustrate a non-luer connector600 that includes a non-luer element 650 that prevents attachment of astandard female luer connector, for example needle hub 130 describedabove. The non-luer connector 600 of FIGS. 35-41 is shown integrallyformed with a container in the form of a syringe barrel 610, asdescribed above with reference to FIGS. 14-22. The container may beprovided in other forms, for example, a drug bag, epidural pump or othercontainers known in the art. The syringe barrel 610 shown in FIGS. 35-41includes a distal wall 618 and a tip 632 that extends in the distaldirection from the distal wall 618. The tip 632 includes a passageway642 and an opening 634 in fluid communication with the chamber of thesyringe barrel 610. The tip 632 has a distal end 636 and a proximal end639.

The outside surface 638 of the tip may have a dimension and/or shapethat forms an interference fit connection and/or fluid-tight engagementwith the outside surface of a corresponding non-luer connector, forexample, the female non-luer connector 200. It will be appreciated,however, that the dimension and/or shape of the outside surface 638 ofthe tip according to the invention may permit the user to force anincorrect interference fit connection and/or fluid-tight engagement ofthe non-luer connector 600 with a standard female luer connector. Aswill be described below, the non-luer element 650 prevents suchincorrect connection or engagement thereof. In one or more embodiments,the outside surface 638 of the tip has a dimension and/or shape thatprevents forcing of an interference fit connection and/or fluid-tightengagement with a standard female luer connector but permits suchconnection and/or engagement with a corresponding non-luer connector.

In one or more embodiments, the outside surface 638 of the tip has anouter cross-sectional dimension as described with reference to FIGS.29-34. In one or more embodiments, the outside surface 638 of the tip632 may have a taper as also described with reference to FIGS. 29-34.The outside surface 638 of the tip 632 of one or more embodiments mayhave a length as described with reference to FIGS. 29-34.

The non-luer element 650 is integrally formed or provided in thecontainer. Specifically, in the embodiment shown in FIGS. 35-41, thenon-luer element 650 is integrally formed and disposed on outsidesurface 638 of the tip 632. The non-luer element 650 extends radiallyoutwardly from the outside surface 638 of the tip. The non-luer element650 includes an exterior surface 652 that defines an outercross-sectional dimension that is greater than the outer cross-sectionaldimension of the tip 632, when measured from the outside surface 638 ofthe tip. In the embodiment shown, the non-luer element 650 is shown as acircular disc having at least one narrowing edge 654.

The non-luer element 650 is disposed between the distal end 636 and aproximal end 639 of the tip 632. In the embodiment shown, the non-luerelement 650 is disposed approximately at a mid-point between the distalend 636 and a proximal end 639. In one or more alternative embodiments,the non-luer element 650 may be disposed adjacent to or at the distalend 636 of the tip 632. Optionally, the non-luer element 650 may bedisposed adjacent to or at the proximal end 639 of the tip 632.

The position of the non-luer element 650 in one or more embodiments maybe modified to prevent connection of a standard female luer connector tothe tip 632. Specifically, in one or more embodiments, the non-luerelement 650 may be disposed closer to the distal end 636 of the tip 632to allow fluid-tight engagement only of corresponding female non-luerconnectors having an inside cavity of shorter length than the cavity ofstandard female luer connectors. Accordingly, the non-luer element 650prevents the standard female luer connector from fully sliding in theproximal direction over the tip 632 and prevents formation of aninterference fit connection and/or fluid-tight engagement between thestandard female luer connector and the tip 632. That is, the standardfemale luer connector will contact the non-luer element 650 before ithas been moved sufficiently proximally on the tip 632 to form afluid-tight connection by contact of the outside surface 638 of the tipwith the inner surface of the standard female luer connector.

The non-luer element 650 of the embodiment shown in FIGS. 35-41 has across-section that has an outer cross-sectional dimension that isgreater than the inner cross-sectional dimension of a standard femaleluer connector, for example, the luer connector 133 of needle hub 130shown in FIG. 4. Specifically, the outer cross-sectional dimension ofthe non-luer element 650 prevents the open proximal end of the standardfemale luer connector, for example, the hub body 132, from sliding overor fitting over the outside surface 638 of the tip and fully engagingthe outside surface 638 of the tip 632. In other words, the non-luerelement 650 functions as a barrier to movement of the luer connectorover the tip 632 in the proximal direction.

In one or more embodiments, the outer cross-sectional dimension of thenon-luer element 650 is in the range from about 0.175 inches to about0.500 inches. In one or more specific embodiments, the outercross-sectional dimension of the non-luer element 650 is in the rangefrom about 0.175 inches to about 0.305 inches or from about 0.306 inchesto about 0.500 inches. The upper limit of the outer cross-sectionaldimension of the non-luer element 650 includes 0.300 inches, 0.302inches, 0.304 inches, 0.306 inches, 0.308 inches and 0.310 inches. Thelower limit of the cross-sectional dimension of the non-luer element 650includes 0.170 inches, 0.172 inches, 0.174 inches, 0.176 inches, 0.178inches and 0.180 inches.

In the embodiment shown in FIGS. 35-41, the non-luer element 650 may beprovided as a continuous and singular disc-like structure that extendscontinuously circumferentially around the tip 632. In one or moreembodiments, the non-luer element 650 may be provided in the form ofdiscrete projections disposed around a portion of the circumference ofthe outside surface 538 of the tip 532. Spaces may be provided betweenthe projections. In embodiments that incorporate discrete projectionsand/or spaces there between, in the event a standard female luerconnector is able to fit over the non-luer element 650 such that theinside surface of the luer connector is in contact with the exteriorsurface 652 of the non-luer element 650, the spaces would prevent orinhibit the formation of a fluid-tight seal by providing areas of thenon-luer element 650 and/or outside surface 638 of the tip that are notin contact with the inside surface of the luer connector. In one or morespecific embodiments, the spaces would result in openings from theinterior of the standard female luer connector to the outside surface638 of the of the non-luer connector that would cause the fluid to leak.

In the embodiment shown, the non-luer element 650 has a circularcross-section. In one or more embodiments, the non-luer element 650 mayhave a square, triangular cross-section or other non-circularcross-section, which would prevent a standard female luer connectorhaving a circular cross-section, for example the luer connector 133 ofneedle hub 130 of FIG. 4. Specifically, the hub body 132 of needle hub130 would be prevented from fitting or sliding over the non-luer element650 such that the tip 632 and the inside surface 134 of the hub body 132would not be able to form an interference fit connection and/orfluid-tight engagement with the outside surface 638 of the tip 632.Accordingly, the non-luer element 650 prevents connection of a standardfemale luer connector to the syringe barrel 610 of the non-luerconnector 600. Specifically, if the non-luer element 650 has anon-circular outer cross-sectional dimension that is smaller than theinner cross-sectional dimension of the standard circular female luer,there will be gaps in the contact points between the non-luer element650 and/or tip 632 that would cause the fluid to leak.

As will be described below, the non-luer element 650 is positioned onthe tip 632 to permit connection of the tip 632 to another correspondingnon-luer connector. For example, the cavity 216 of a female non-luerconnector 200 may have length that is equal to the length of the tip 632from its distal end 636 to the non-luer element 650 such that the insidesurface 214 forms an interference fit connection and/or fluid-tightengagement with the exterior surface 638 of tip 632. Accordingly, in oneor more embodiments, the non-luer element 650 is positioned such thatthe length of the tip 632 between a point distally adjacent to thenon-luer element 650 and the distal end 636 of the tip is less than orequal to the length of the cavity 216 of the female non-luer connector200 to permit formation of an interference fit connection and/orfluid-tight engagement between the tip 632 and the female non-luerconnector 200.

In one or more embodiments, the non-luer element 650 is positioned,shaped and/or sized to have an outer cross-sectional dimension thatprevents connection of the tip 632 to a standard female luer connectorthat includes a valve or seal, as described above with reference toFIGS. 29-34. In one or more embodiments, the non-luer element 650 ispositioned such that the standard female luer connector is preventedfrom sliding over the length of the tip 632 such that, upon penetrationof the valve or seal by the tip 632, the opening 634 of the tip 632remains adjacent or near the open proximal end of the standard femaleluer connector but does not enter the cavity sufficiently to cause anysubstantial contact between the outside surface of the tip 632 and theinside surface of the standard female luer connector. That is, the valveor seal of the standard female luer connector contacts the non-luerelement 650 and prevents further proximal movement of the standardfemale luer connector before substantial contact between the tip 632 andthe standard female luer connector is achieved. The position of theopening 634 compromises the sealing ability of the valve or sealdisposed within the cavity of the standard female luer connector andvisible leakage occurs despite the presence of the valve or seal.Accordingly, the non-luer connector 600 minimizes the risk that a usercan inadvertently utilize the non-luer connector 600 described hereinwith an unintended standard female luer connector.

In use, to assemble the non-luer connector 600 to a correspondingnon-luer connector, for example, the female non-luer connector 200 shownin FIGS. 5-13, the tip 632 of the non-luer connector 600 is disposedwithin the cavity 216 of the hub. A force is applied in the distaldirection on the non-luer connector 600 until the outside surface 638 ofthe tip 632 engages the inside surface 214 of the wall of the femalenon-luer connector 200 in an interference fit connection and/orfluid-tight engagement.

One or more embodiments of a non-luer connector 700 for use in a drugdelivery device according to the third aspect of the present inventionare shown in FIGS. 42-63. FIGS. 42-63 illustrate a non-luer connector700 that includes structure to prevent the formation of a fluid-tightconnection between the non-luer connector 700 and a standard female luerconnector by increasing the leakage or possibility of leakage of liquidin a misconnection. The non-luer connector 700 also has structure thatenables attachment of the non-luer connector 700 to anothercorresponding non-luer connector, for example, the female non-luerconnector 200. The non-luer connector 700 of FIGS. 42-63 is shownintegrally formed to a container, provided in the form of a syringebarrel 710, as described above with reference to FIGS. 14-22. Thecontainer may be provided in other forms, for example, a drug bag,epidural pump and other containers known in the art. The syringe barrel710 shown in FIGS. 42-63 includes a distal wall 718. A tip 732 extendsin the distal direction from the distal wall 718 and includes apassageway 742 and an opening 734 in fluid communication with thechamber of the syringe barrel 710. The tip 732 has a distal end 736 anda proximal end 739. The tip includes an end wall 740 disposed at thedistal end 736 that extends from the opening 734 to the outside surface738 of the tip.

The outside surface 738 of the tip may have a dimension and/or shapethat prevent the formation of a fluid-tight engagement with the insidesurface of a standard female luer connector. In the embodiment shown,the tip 732 includes a non-luer element that is integrally formedthereon. Specifically, the end wall 740 includes a notch 743 or otherstructure for enlarging the opening 734 of the tip such that it extendsto the outside surface 738 of the tip. In other words, the notch 743provides a path for fluid to escape from the opening 734 to the outsidesurface 738 of the tip even when the end wall 740 is pressed against aflat surface, such as the end wall of the cavity of a standard femaleluer, provided that the inside surface 214 of the cavity 216 does notform a tight interference fit with the outside surface 738 of thenon-luer tip 732. To accomplish this, the notch 743 extends from thepassageway through the sidewall to form an aperture in the side wall atthe distal end of the tip. The notch 743 may provide a beveled or curvededge to the distal end 736 of the tip 732 adjacent to the outsidesurface 738 of the tip that forms an aperture in the side wall at thedistal end of the tip.

To establish fluid-tight engagement between the tip 732 and a hub orconnector, regardless of whether the hub or connector has a standardfemale luer connector or female non-luer connector, a fluid-tight sealis typically formed between the outside surface 738 of the tip andinside surface of the female connector. If a fluid-tight seal is notformed between the inside surface of the female connector (i.e., thecavity) and the tip 732, a fluid-tight engagement will not be formedbetween the female connector and the tip 732. If fluid-tight engagementis not formed, leakage may or may not occur for the following reason.

In embodiments in which the outside surface 738 of a tip 732 has anouter cross-sectional dimension that prevents formation of a fluid-tightseal with the inside surface of a female connector cavity, the distalend 736 of the tip 732 may have a dimension that allows the end wall 740of the tip 732 to contact the distal end of the inside surface of thecavity and potentially form at least a partially fluid-tight seal. Thatcould allow a user to utilize the tip 732 with a standard female luerconnector. In such situations, the leakage that may occur from the sealbetween the end wall 740 of the tip 732 and the distal end of the femaleconnector cavity, even if only partial, may be too minimal to be noticedby the practitioner.

In the embodiment shown in FIGS. 42-63, the notch 743 disposed on theend wall 740 prevents the formation of a fluid-tight seal between theend wall 740 and the distal inside surface of a standard female luerhub, for example, the inside surface 134 of the needle hub 130, becauseit provides a larger outlet or avenue for leakage of the fluid withinthe container. The notch 743 thus prevents the formation of afluid-tight seal at the end wall 740 of the tip 732 by providing anoutlet into the side space between tip 732 and the hub even if end wall740 of tip is in fluid-tight contact with the distal inside surface ofthe hub cavity. Accordingly, the notch 743 maximizes leakage between thetip 732 and the standard female luer connector if the connection therebetween is improper because a fluid-tight seal is not formed at the endwall 740 and the fluid is permitted to leak between the inside surface134 of the hub and the outside surface 738 of the tip.

For a hub or connector to properly establish a fluid-tight engagement atthe end wall 740, the female non-luer connector must have a dimensionand/or shape to accommodate and enclose the notch 743. The insidesurface 214 of female non-luer connector 200 may be shaped to have ataper which corresponds to the taper of the non-luer male tip, thusproviding close contact between the outside surface of the tip and theinside surface of the female connector and substantially eliminating anyspace between them that could channel leaking fluid out of the femaleconnector. This fully encloses or seals the notch 743 and preventsleakage of the fluid from the correct non-luer male-female connection.

The notch 743 has a dimension and/or shape that prevents the insidesurface of a standard female luer connector from enclosing or sealingthe notch 743. In one or more embodiments, the tip 732 may have adimension, taper or shape that allows the notch 743 to be positioned ordisposed in a manner in which the inside surface of a standard femaleluer connector cannot enclose or seal the notch 743. Specifically, inembodiments in which the outside surface 738 of the tip has a taper,length and/or outer cross-sectional dimension that prevents formation ofa fluid-tight with a standard female luer connector, the notch 743 maybe positioned, have a dimension or shape that prevents the insidesurface of the standard female luer connector from contacting orsufficiently enclosing or sealing the notch 743. In one or moreembodiments, the length of the tip 732 may be modified such thatattachment of a standard female luer connector to the tip 732 createsdead space within the standard female luer connector and the tip 732that prevents the formation of a seal between the standard female luerconnector and the notch 743. In general, the notch will have a depthmeasured from the end wall 740 toward the proximal end 739 of the tip732 that is sufficient to result in visible leakage into the dead spaceof an incorrect male-female connection but not large enough to cause acorrect connection to leak in spite of adequate contact between theoutside surface of the tip and the inside surface of the female cavity.

In one or more embodiments, the notch 743 has a depth measured from theend wall 740 toward the proximal end 739 of the tip 732 in the rangefrom about 0.010 inches to about 0.100 inches. In one or more specificembodiments, the depth of the notch 743 may be in the range from about0.01 inches to about 0.049 inches or from about 0.500 inches to about0.100 inches. The upper limit of the depth of the notch 743 includes0.040 inches, 0.042 inches, 0.044 inches, 0.046 inches, 0.048 inches,0.050 inches, 0.052 inches, 0.054 inches, 0.056 inches, 0.058 inches and0.060 inches. The lower limit of the depth of the notch 743 includes0.005 inches, 0.006 inches, 0.007 inches, 0.008 inches, 0.009 inches,0.012 inches, 0.014 inches, 0.016 inches, 0.018 inches and 0.02 inches.The notch 743 of one or more embodiments may have a width orcross-sectional dimension in the range from about 0.010 inches to about0.080 inches. In one or more specific embodiments, the notch 743 has awidth in the range from about 0.01 inches to about 0.049 inches or fromabout 0.05 inches to about 0.08 inches. The upper limit of the width ofthe notch 743 includes 0.040 inches, 0.042 inches, 0.044 inches, 0.046inches, 0.048 inches, 0.050 inches, 0.052 inches, 0.054 inches, 0.056inches, 0.058 inches and 0.060 inches. The lower limit of the width ofthe notch 743 may include, 0.005 inches, 0.006 inches, 0.007 inches,0.008 inches, 0.009 inches, 0.012 inches, 0.014 inches, 0.016 inches,0.018 inches and 0.02 inches.

The notch 743 of FIGS. 42-48 is shown as an indentation in the wall thatextends through the width of the end wall 740. The notch 743 may becharacterized as two notches that are disposed on opposite sides of theopening 734.

In the embodiment shown in FIGS. 49-56, the end wall 740 may include twonotches 744,746. In the embodiment shown, the two notches 744, 746 aredisposed at a right angle with respect to each other, when measured fromthe opening 734. In one or more alternative embodiments, additionalnotches may be added. The notches may be spaced at regular or irregularintervals from each other. The notch of FIGS. 49-56 may also bedescribed as four separate notches that are disposed across the end wall740 and which radiate outwardly from the opening 734. The four notchesare shown as disposed at 90 degree intervals, when measured from theopening 734.

In the embodiment shown in FIGS. 57-63, the end wall 740 may include aplurality of notches 750 that are disposed adjacent to one another alongthe circumference of the distal end. The plurality of notches 750surrounds the opening of the tip 732. The plurality of notches 750 havea wedge shape, wherein each of the plurality of notches 750 extends intothe end wall 740 and forms a point. In other words, the plurality ofnotches has a zigzag profile. In one or more embodiments, each of theplurality of notches 750 have a first side 752 that has a decreasingslope that extends in the proximal direction into the end wall and asecond side 754 that has an increasing slope that extends from the firstside in the distal direction to the first side of an adjacent notch. Anedge 755 connects the first side and the second side. The edge 755 isshown as being angled and/or having a slope that decreases from theoutside surface 738 to the opening 734. The plurality of notches 750 mayhave a height that, when measured from the end wall 740 increases fromthe opening 734 to the outside surface 738 of the tip. In other words,the plurality of notches 750 may be angled toward the opening 734 of thetip.

In one or more embodiments, the angled plurality of notches 750 includea cutting edge 756 that is adapted to pierce or cut a valve or seal thatmay be utilized with a standard female luer connector, as describedabove with reference to FIGS. 29-34 and 35-41. Specifically, when a userattempts to assemble a standard female luer connector with a valve orseal to a non-luer connector 700, the cutting edge 756 of the pluralityof notches cuts and/or pierces the valve or seal thereby preventing thevalve or seal from minimizing the leakage between the improperlyconnected non-luer connector 700 and the standard female luer connector.In addition, the cutting edge 756 of one or more embodiments may alsodamage the standard female luer connector, further discouraging orpreventing connection of a standard female luer connector to thenon-luer connector 700. Accordingly, the cutting edge 756 minimizes therisk that a user can utilize the non-luer connector 700 described hereinwith an unintended standard female luer connector.

In one or more embodiments, the notch 743 disposed on the end wall 740may be used in conjunction with a plurality of barrier walls 552 thatform at least one aperture 557 or a plurality of apertures spacedbetween the barrier walls 552 to prevent the formation of a fluid-tightseal between the end wall 740 and the distal inside surface of astandard female luer hub by providing openings to the exterior of theconnector that will result in leakage of fluid delivered through thetip. The apertures 557 of the embodiment extend from the distal end 558to the proximal end 559 of the barrier wall. In one or more alternativeembodiments, the apertures 557 may extend from the distal end 558 to adistance between the distal end 558 and the proximal end 559.

In one or more embodiments, the outside surface 738 of the tip may havean outer cross-sectional dimension and/or taper as described above withreference to FIGS. 29-34. The tip 732 of one or more embodiments mayalso have a length as described above with reference to FIGS. 29-34.

In use with a corresponding non-luer connector, for example, the femalenon-luer connector 200 of FIGS. 5-13, the tip 732 is inserted into thecavity 216 of the female non-luer connector 200. A force is applied tothe syringe barrel 710 in the distal direction and/or to the femalenon-luer connector 200 in the proximal direction to cause the insidesurface 214 of the wall 212 of the female non-luer connector to engagethe outside surface 738 of the tip 723 in an interference fit connectionand/or fluid-tight engagement. To remove the female non-luer connector200 from the syringe barrel 710, a force is applied to the container inthe proximal direction and/or to the female non-luer connector 200 inthe distal direction to disengage the interference fit connection and/orthe fluid-tight engagement of there between.

In one or more embodiments, the notch 743, notches 744, 746 andplurality of notches 750 may be utilized with male connectors that willadopt proposed new standards for neuraxial applications. Specifically,under ISO 80369-6, for small bore connectors for liquids and gases inhealthcare applications, the taper of the male connector and femaleconnector will be modified from the existing ISO luer standard of 6% to5% from their proximal ends to the distal ends. For male connectors, thenew 5% taper provides a more gradual decrease in the outercross-sectional dimension of the connector from the proximal end to theopen distal end. For female connectors, the new 5% taper provides a moregradual decrease in the inner cross-sectional dimension of the connectorfrom the open proximal end to the distal end, as shown in FIG. 64. Inaddition, the outer cross-sectional dimension at the open distal end ofthe male connector will be less than the range of the current ISO luerstandard of 0.1545 inches to 0.1585 inches. Specifically, the currentproposed ISO standards provide for the outer cross-sectional dimensionfor the male connector at the open distal end to measure in the rangefrom about 0.1306 inches to about 0.1326 inches. The innercross-sectional dimension of the female connector at the open proximalend will be less than the range of the current ISO luer standard of0.168 inches to 0.170 inches. Specifically, the current proposed ISOstandards provide for the inner cross-sectional dimension for the femaleconnector at the open proximal end to measure in the range from about0.1417 inches to about 0.1437 inches. The length of the male connectorfor neuraxial applications will also be increased from 0.295 inches toabout 0.300 inches. The length of female connectors for neuraxialapplications will also be increased from 0.295 inches to about 0.303inches.

The more gradual taper in the new ISO standards for neuraxialapplications for both male and female connectors and the smaller outercross-sectional dimension and inner cross-sectional dimensions of themale and female connectors, respectively, are intended to prevent fluidtight connection of a male connector for a neuraxial application with afemale standard luer connector and a female connector for a neuraxialapplication with a male standard luer connector. However, the smallerouter cross-sectional dimension of the male connector for neuraxialapplications at the distal end thereof may make it possible for a userto inadvertently or purposely attach the male connector for neuraxialapplications to a female standard luer connector, which may have aninner cross-sectional dimension at its distal end that could accommodatethe smaller outer cross-sectional dimension of the male connector forneuraxial applications. The ability to attach the male connector forneuraxial applications to a female standard luer connector, even if notideal, could allow the formation of at least a partial fluid-tightengagement sufficient to deliver unintended fluids or liquids to apatient at an incorrect delivery site.

The notch 743, notches 744, 746 and plurality of notches 750 describedherein connect the opening 734 to the outside surface 738 of the tip,preventing partial fluid-tight connection between the distal end of thetip and the distal wall of a larger standard female connector, such thata user would not be able establish sufficient fluid-tight engagement toutilize a male connector for neuraxial applications that is incorrectlyattached to a female standard luer connector. Specifically, the notches743, notches 744, 746 and plurality of notches 750 increase leakage fromsuch an incorrect connection and prevent circumvention of the new ISOproposals for neuraxial applications.

One or more embodiments of the present invention may incorporate avisual indicator to provide visual indication of the compatibility ofthe components of the drug delivery devices described herein.Specifically, a container having a non-luer connector may have a coloror be made from a colored polymeric material that corresponds to thecolor of a correct corresponding female non-luer connector. In one ormore embodiments, the plunger rod of a syringe may also have a colorthat corresponds to a correct corresponding female non-luer connector.The visual indicators may be placed on the hub body and/or the needleshield of the female non-luer connector. Other visual indicators mayinclude labeling that conveys that the container and/or female non-luerconnector include a non-luer connector.

Reference throughout this specification to “one embodiment,” “certainembodiments,” “one or more embodiments” or “an embodiment” means that aparticular feature, structure, material, or characteristic described inconnection with the embodiment is included in at least one embodiment ofthe invention. Thus, the appearances of the phrases such as “in one ormore embodiments,” “in certain embodiments,” “in one embodiment” or “inan embodiment” in various places throughout this specification are notnecessarily referring to the same embodiment of the invention.Furthermore, the particular features, structures, materials, orcharacteristics may be combined in any suitable manner in one or moreembodiments.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It will be apparent to those skilled in the art thatvarious modifications and variations can be made to the method andapparatus of the present invention without departing from the spirit andscope of the invention. Thus, it is intended that the present inventioninclude modifications and variations that are within the scope of theappended claims and their equivalents.

What is claimed is:
 1. A device comprising: a container having an open distal end including a distal wall, a sidewall including an inside surface defining a fluid chamber for retaining fluids, an elongate tip extending in a distal direction from the distal wall, the elongate tip including an opening for providing access to the chamber, and a non-luer connector for connection to a female non-luer connector, wherein the non-luer connector comprises a non-luer element disposed at the open distal end configured to cause leakage between a standard luer connector and the container when the standard luer connector is attached to the container; wherein the non-luer element includes a plurality of barrier walls forming at least one aperture spaced between the plurality of barriers walls; wherein the non-luer element prevents connection of the standard luer connector; wherein the non-luer element has a distal end and a proximal end and the at least one aperture extends from the distal end of the non-luer element to the proximal end of the non-luer element; wherein the plurality of barrier walls taken together have a circular cross-section and an outer cross-sectional diameter of the plurality of barrier walls is less than an inner-cross sectional diameter of the standard luer connector that causes leakage between the standard luer connector and the plurality of barrier walls.
 2. The device of claim 1, wherein the non-luer element extends in the distal direction from the distal wall of the container and is disposed coaxially around the elongate tip, the non-luer element forming a channel between the elongate tip and the non-luer element for receiving a portion of the female non-luer connector.
 3. The device for claim 2, wherein the distal end of the non-luer element extends distally past the elongate tip.
 4. The device of claim 2, wherein the elongate tip includes a distal end that extends distally past the non-luer element.
 5. The device of claim 2, wherein the plurality of barriers wall have a length that is less than or equal to a length of the elongate tip.
 6. The device of claim 2, wherein the plurality of barriers wall have a length that is greater than or equal to a length of the elongate tip.
 7. The device of claim 1, wherein the at least one aperture provides access to a channel between the elongate tip and the non-luer element.
 8. The device of claim 7, wherein the at least one aperture includes at least two apertures and has a curved cross-section between the at least two apertures.
 9. The device of claim 1, wherein the at least one aperture provides visual indication of whether the non-luer connector comprises a luer slip fitting or a luer lock fitting.
 10. The device of claim 1, wherein the at least one aperture has a dimension selected to prevent formation of a fluid-tight seal between the non-luer element and the standard luer connector, wherein the standard luer connector is a standard female luer connector.
 11. The device of claim 1, wherein the plurality of barrier walls have a plurality of threads disposed thereon for engaging a corresponding structure of the female non-luer connector.
 12. An assembly comprising: the device of claim 1 and the female non-luer connector, the female non-luer connector being removably attached to the elongate tip of the container, the female non-luer connector including a hub body including an open proximal end, an interior surface defining a cavity dimensioned for fluid-tight connection of the female non-luer connector to the elongate tip and a needle cannula attached to the hub body, the needle cannula including an open distal end in fluid communication with the cavity. 